characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

in premenopausal breast cancer patients & to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.

Original Primary Outcome Measures ICMJE (submitted: January 14, 2009)

To characterize the changes in serum AMH from baseline to one year post-chemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer and lymphoma patients. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

To characterize the changes in serum estradiol and FSH from baseline to one year postchemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer patients and BRCA mutation carriers. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

To characterize the changes over time in serum AMH, estradiol, and FSH in premenopausal breast cancer patients and unaffected high risk BRCA mutation carriers. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

To describe the impact of commonly used therapies for early-stage breast cancer on self-reported monthly menstrual cycles and future pregnancy/reproductive health. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

To study sexual health and function in unaffected high risk BRCA mutation carriers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

To characterize the changes in serum estradiol and FSH from baseline to one year postchemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer and lymphoma patients. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

To characterize the changes over time in serum AMH, estradiol, and FSH in premenopausal breast cancer and lymphoma patients. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

To describe the impact of commonly used therapies for early-stage breast cancer and lymphoma on self-reported monthly menstrual cycles and future pregnancy/reproductive health. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations

Official Title ICMJE

Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer BRCA Mutations

Brief Summary

The purpose of this study is to see how the cancer treatment affects the ovaries. Cancer treatment can make it hard for a person to conceive a child in the future. It may also bring on early menopause. We will check blood levels of hormones that the ovaries produce. We will do this before, during, and after the cancer treatment. We will also ask the patient to fill out questionnaires about their menstrual cycle (periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.

Detailed Description

Not Provided

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

blood

Sampling Method

Non-Probability Sample

Study Population

Patients of premenopausal women with early-stage breast cancer will be recruited from the Breast Cancer Service at MSKCC and New York Presbyterian Hospital-Weill Medical College of Cornell University. In addition, breast cancer patients seeking consultation with a reproductive endocrinologist to address issues of fertility preservation prior to the start of therapy will be offered participation (Dr. Oktay at New York Medical College.

Patients of unaffected high risk premenopausal women with BRCA mutations will be recruited from the Breast Cancer Services especially the high risk surveillance clinics at MSKCC and New York Presbyterian Hospital-Weill Medical College of Cornell Univeristy.

a. AJCC Stage 0-III breast cancer, regardless of hormone-receptor status or HER2-overexpression, before the start of planned adjuvant or neoadjuvant chemotherapy and/or hormonal therapy. If chemotherapy is planned, the regimen must be either CMF, anthracycline containing, or taxane containing. If hormonal therapy is planned, the regimen must be limited to tamoxifen. All biologics (e.g. bevacizumab, trastuzumab, lapatinib, etc.) are allowed in addition to the above therapies.

ECOG performance status 0-1

Have regular menstrual cycles; patients can have no more than 1 irregular cycle (too early or too late) within the past year and/or at least 10 spontaneous cycles within the past year.

Subject Inclusion:

For Unaffected High Risk Premenopausal Women with BRCA mutations

Premenopausal Women ages 30-45 with known BRCA mutations

ECOG performance status 0-1

Have regular menstrual (21-35 days); patients can have no more than 1 irregular cycle (too early or too late) within the past year and/or at least 10 spontaneous cycles within the past year.

No history of breast or ovary cancer.

Exclusion Criteria:

For Cohort of Premenopausal Women with Early Stage Breast Cancer

Prior therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or immunotherapy.

Plans for risk-reducing bilateral oophorectomy within one year of completion of chemotherapy.

Prior known infertility; infertility is defined as one year of inability to conceive despite unprotected intercourse and/or the need to use medication (e.g clomiphene) or assisted reproductive technology (e.g. intrauterine insemination or in vitro fertilization) to attempt pregnancy.

Family history of a first-degree relative with non-surgical menopause < age 40

Current pregnancy.

Subject Exclusion Criteria:

For Unaffected High Risk Premenopausal Women with BRCA mutation

Prior chemotherapy or immunotherapy for breast cancer or any other cancer

Prior known infertility; (except women who have undergone voluntary tubal ligation); infertility is defined as one year of inability to conceive despite unprotected intercourse and/or the need to use medication (e.g clomiphene) or assisted reproductive technology (e.g. intrauterine insemination or in vitro fertilization) to attempt pregnancy.

Family history of a first-degree relative with non-surgical menopause < age 40